Bulk Pharmaceutical API Sources for ATROMID-S

Bulk Pharmaceutical API Sources for ATROMID-S

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		C6643_SIGMA
TCI (Tokyo Chemical Industry)		C0941
Molport		MolPort-000-145-477

Bulk Active Pharmaceutical Ingredient (API) Sources for ATROMID-S

Last updated: July 29, 2025

---

Introduction

ATROMID-S, universally recognized as metronidazole, is a widely used antimicrobial agent primarily indicated for anaerobic infections, protozoal diseases, and various bacterial infections. Manufacturing quality and supply chain stability of its Active Pharmaceutical Ingredient (API) are critical for ensuring therapeutic efficacy, regulatory compliance, and cost-effectiveness. Identifying credible bulk API sources is a vital component for pharmaceutical companies aiming to manufacture ATROMID-S at scale. This article provides a comprehensive overview of key API producers globally, their capabilities, regulatory standing, and market trends to inform procurement strategies.

---

Overview of Metronidazole API Market

The global market for metronidazole API hinges on factors such as manufacturing capacity, regulatory approvals, cost competitiveness, and supply chain reliability. The API is synthesized via nitration and reduction pathways, requiring specialized chemical process expertise and stringent quality controls compliant with international standards like USP, EP, and JP.

Major API suppliers operate across Asia, Europe, and North America, with Asia dominating in volume and cost advantages. The regulatory landscape varies, with suppliers holding approvals from agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the World Health Organization (WHO). The following analysis details prominent sources distinguished by manufacturing footprint, compliance credentials, and market reputation.

---

Leading API Manufacturers for ATROMID-S (Metronidazole)

1. Zhejiang Ng Pharmachem Co., Ltd. (China)

Zhejiang Ng Pharmachem is a prominent API producer with extensive manufacturing capabilities in China. The facility adheres to cGMP standards and holds certifications from major regulatory agencies, including FDA and EMA. The company offers metronidazole with consistent quality, supporting pharmaceutical export and bulk supply needs. Its strategic location and large-scale production enable competitive pricing and reliable large-volume supplies.

Strengths:

• cGMP compliant manufacturing facility
• Certified by multiple international regulators
• Economies of scale offering cost advantages
• Export experience across continents

Limitations:

• Potential regulatory scrutiny due to regional perceptions
• Reliance on regional supply chain stability

2. Hetero Labs Limited (India)

Hetero Labs is one of India’s largest API manufacturers, with a diversified product portfolio including metronidazole API. The company boasts ISO 9001, WHO-GMP, and other certifications, ensuring high-quality production standards. Their sourcing of raw materials and adherence to stringent quality controls positions them as a dependable supplier.

Strengths:

• Proven manufacturing expertise and regulatory compliance
• Significant capacity for bulk API production
• Cost-competiveness rooted in Indian API manufacturing landscape

Limitations:

• Variability in regional logistics
• Procurement timelines influenced by global demand

3. Teva API (India & Israel)

Teva Pharmaceutical Industries, known for its global API manufacturing network, produces metronidazole for both generic and proprietary formulations. Their API facilities in India and Israel meet international quality standards, ensuring high purity and batch consistency. Teva’s extensive distribution channels and regulatory approvals make it a preferred partner for large-volume needs.

Strengths:

• Established track record of high-quality API production
• Global regulatory acceptance
• Integrated supply chain infrastructure

Limitations:

• Higher price points compared to regional players
• Stringent compliance protocols

4. Sinopharm Chemical Reagent Co., Ltd. (China)

A subdivision of China National Pharmaceutical Group (Sinopharm), this manufacturer supplies APIs including metronidazole to international markets. The company complies with ISO standards and holds certifications necessary for export, serving both generic and hospital markets.

Strengths:

• Large-scale manufacturing capacity
• Competitive pricing
• International certifications

Limitations:

• Regulatory transparency challenges
• Variability in supply consistency

5. Sandoz (Novartis) (Europe/India)

As part of Novartis, Sandoz supplies high-quality APIs globally, including metronidazole. Their manufacturing units in Europe and India are equipped with state-of-the-art facilities and adhere to GMP standards. Sandoz’s reputation for quality control makes them suitable for regulatory-sensitive markets.

Strengths:

• Global standards and certifications
• Reliable supply chain
• Strong quality assurance programs

Limitations:

• Premium pricing
• Smaller manufacturing capacity compared to regional suppliers

---

Regulatory Considerations for API Sourcing

Regulatory compliance is paramount when selecting API suppliers. Suppliers with approvals from entities such as the FDA, EMA, WHO, or approvals recognized via Good Manufacturing Practices (GMP) certifications offer assurance of quality. For global markets, vendors possessing multiple regulatory accreditations reduce approval timelines and mitigate compliance risks.

In addition to certifications, manufacturers should demonstrate stability in batch production, robust quality control systems, and transparency in sourcing raw materials. Audits and supplier qualification processes serve as essential steps before onboarding new API vendors.

---

Emerging Trends in API Supply

The API procurement landscape for metronidazole reflects broader pharmaceutical trends. Increasing adoption of continuous manufacturing enhances process efficiency, while digital quality monitoring improves batch consistency. Suppliers investing in advanced process analytical technologies (PAT) are better positioned to meet stringent quality standards.

Regional diversification of supply chains is also gaining importance to mitigate risks associated with geopolitical uncertainties or logistic disruptions, as exemplified during the COVID-19 pandemic. Coupled with evolving regulatory harmonization, these trends influence strategic API sourcing decisions for ATROMID-S.

---

Market Challenges and Risk Management

The volatility in raw material costs, geopolitical influences, and regulatory shifts present inherent risks in API procurement. Counterfeit risks and ethical sourcing of raw materials further complicate supply chain integrity. Therefore, partnering with reputable, well-audited suppliers with proven track records is advisable to ensure quality, reliability, and regulatory compliance.

Additionally, companies should consider establishing secondary supplier relationships to prevent supply interruptions. Contract manufacturing organizations (CMOs) with proven capabilities can also serve as reliable alternatives.

---

Key Factors in Selecting API Suppliers for ATROMID-S

• Regulatory compliance: FDA, EMA, WHO certifications
• Manufacturing capacity: Ability to meet demand volumes
• Quality assurance: Consistent batch quality, stability data
• Cost competitiveness: Pricing strategies aligned with market expectations
• Supply chain robustness: Logistics, lead times, raw material sourcing
• Reputation and track record: Regulatory history and past audits

---

Key Takeaways

• Asia, particularly China and India, dominates the metronidazole API supply market due to cost efficiencies and extensive manufacturing infrastructure.
• Suppliers like Zhejiang Ng Pharmachem (China) and Hetero Labs (India) are leading regional players, offering high-quality APIs with global certifications.
• European firms such as Sandoz provide premium quality and regulatory confidence, suitable for markets with stringent standards.
• Ensuring regulatory compliance, quality control, and supply chain stability are critical factors when selecting API sources for ATROMID-S.
• Emerging trends such as digital manufacturing and diversified supply chains are shaping future procurement strategies.

---

FAQs

1. What are the primary factors influencing API sourcing decisions for ATROMID-S?
Regulatory compliance, manufacturing capacity, quality assurance, cost, supply chain reliability, and vendor reputation are key considerations.

2. Which regions are considered the most reliable sources for metronidazole API?
Asia (especially China and India) provides cost-effective bulk supply, while Europe offers high-quality, regulated APIs for markets with strict compliance requirements.

3. How does regulatory approval impact API selection?
Suppliers with recognized certifications like FDA, EMA, or WHO-GMP facilitate faster approval processes and compliance assurance in target markets.

4. What risks are associated with API supply dependency?
Risks include supply disruptions, quality variability, geopolitical issues, and counterfeit products, emphasizing the need for multi-source strategies.

5. Are there any emerging suppliers or markets to watch for metronidazole API?
Emerging manufacturers investing in advanced manufacturing technologies in Southeast Asia and Eastern Europe are gaining prominence, promising enhanced quality and supply resilience.

---

Sources

1. [1] Global API Market Analysis, IQVIA, 2022.
2. [2] FDA Drug Master File Database, 2023.
3. [3] European Directorate for the Quality of Medicines & HealthCare (EDQM), 2023.
4. [4] Novartis Sandoz API Portfolio, 2022.
5. [5] Industry Reports on API Manufacturing, MarketsandMarkets, 2023.